Import Alert 45-06

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert Name:

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 07/12/2018 updates specific language to reflect more recent (Generally Recognized as Safe (GRAS) notifications and scientific rationale. The revision also updates the reason for alert, guidance, agency contacts, and the product description section. Changes are bracketed by asterisks (***).

The term stevia, as used in commerce, refers to ***the leaves of*** Stevia rebaudiana (Bertoni) Bertoni, a plant native to various parts of South America.

With regard to use in conventional foods, stevia leaf, ***or its crude extract,*** is not an approved food additive and ***is not considered *** GRAS due to inadequate toxicological information.

With regard to use in dietary supplements, dietary ingredients (including stevia) are not subject to food additive regulations.

Stevia leaves are known to contain high intensity sweetener compounds, which are collectively called steviol glycosides, ***and are approximately 200-300 times sweeter than sucrose***. Stevioside, rebaudioside A, rebaudioside D, rebaudioside M, enzyme-modified steviol glycosides, and other steviol glycosides for which FDA does not have questions following the review of a GRAS notification, individually or in combination, are the principal steviol glycosides used as sweeteners. ***Steviol glycosides*** differ from stevia leaves in that they are purified extracts obtained from the leaves.

Stevia leaf-derived ***products *** are approved for use as sweeteners in foods in Japan, Brazil, Australia, New Zealand, and other countries. Said ***products *** are used in a variety of foods, including teas, and are commonly used as table-top sweeteners.

Historically, stevia leaves and stevia leaf-derived products have been offered for entry both in bulk and in finished products such as teas, drinks, seafood, fruits, vegetables and candies.

CFSAN/Office of Food Additive Safety (OFAS) responded to GRAS notices concerning highly purified steviol glycosides obtained from stevia leaves, wherein FDA did not question the basis for the ***notifiers' GRAS conclusions***. Consequently, products that are/or contain highly purified steviol glycosides (>=95% steviol glycosides on a dried weight basis with stevioside, rebaudioside A, rebaudioside D, rebaudioside M, enzyme-modified steviol glycosides or other steviol glycosides as principal components, for which FDA does not have questions following the review of a GRAS notification, as determined by the method cited below or any other equivalent method) are not subject to detention under this Import Alert. Other steviol glycosides that may be present in these products as minor components of the >=95% total steviol glycosides content specified above include other rebaudiosides, dulcoside A, rubusoside, and steviolbioside.

***It should be noted that steviol glycoside(s) may also be produced by fermentation technology without a need to use stevia leaves in the manufacturing process. In such cases, the import alert does not apply.***

Guidance:

Divisions may detain without physical examination all products identified on the Attachment to this Import Alert.

In addition, if review of the labeling and/or entry documentation reveals stevia leaves or stevia-derived products, Divisions may detain these items under the charge in this import alert, UNLESS:

(1) the product is labeled as a dietary supplement. If stevia leaves or crude extracts obtained from stevia leaves are used in a dietary supplement for a technical effect, e.g., as a sweetener or flavoring agent AND are labeled as such, they are considered unsafe food additives; consequently, said products would be subject to detention. However, in the absence of labeling specifying their use for a technical effect, the use of these substances as a dietary ingredient in a dietary supplement is not subject to the food additive provisions of the Federal Food, Drug & Cosmetic Act;

Or

(2) the product is intended for use solely as a dietary ingredient in the manufacture of a dietary supplement product. If stevia leaves or crude extracts obtained from stevia leaves are used in a dietary supplement for a technical effect, e.g., as a sweetener or flavoring agent AND are labeled as such, they are considered unsafe food additives; consequently, said products would be subject to detention. However, in the absence of labeling specifying their use for a technical effect, the use of these substances as a dietary ingredient in a dietary supplement is not subject to the food additive provisions of the Federal Food, Drug & Cosmetic Act;

Or

(3) the product is or contains highly purified steviol glycosides that meet the specification for ***>=*** 95% steviol glycosides as described above (see Reason for Alert). In this case documentation, ***including*** a certificate of analysis ***and manufacturing process information***, should be provided to demonstrate the ***acceptability *** of the article in question. For questions or issues concerning the composition of the product offered for import (including analytical documentation or principal vs. minor components), Divisions may contact CFSAN/OC/Labeling ***and Dietary Supplement*** Compliance ***Branch***;

Or

(4) documentation exists to demonstrate the product is intended for research. Stevia leaves and stevia-derived substances may be undergoing further study in the United States in research settings as a basis for establishing toxicological information for future safety assessments. Shipments of stevia leaves and stevia-derived substances offered for import are indicated for release when, documentation exists to demonstrate that the ultimate destination and end use of the product is for research purposes and provided there are no other compliance issues;

Or

(5) further processing into highly purified steviol glycosides will meet the specification for ***>=*** 95% steviol glycosides as described above (see Reason for Alert). Stevia leaves and crude extracts obtained from stevia leaves are also indicated for release when, documentation exists to demonstrate that the ultimate destination and end use of these substances is for the production of highly purified steviol glycosides that will meet the specification for ***>=*** 95% steviol glycosides as described above (see Reason for Alert) and provided there are no other compliance issues.

If Divisions determine through review of certificate of analysis or manufacturing information that a food product contains stevia leaves and/or crude stevia extracts that do not meet the specification for highly purified steviol glycosides as described above (see Reason for Alert), a recommendation for detention without physical examination should be forwarded to the Division of Import Operations (DIO), HFC-170; UNLESS the product is labeled as a dietary supplement or for use solely as a dietary ingredient in the manufacture of a dietary supplement product.

Reference to any commercial materials, equipment, or processes does not in any way constitute approval, endorsement, or recommendation by FDA.

In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis using FDA recommended methods.

***To remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act). For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)," available at: http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm179271.htm.

If a firm and/or a representative thereof wishes to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at ORAOISMDSSIMPCOMPLSYSBR@FDA.HHS.GOV.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at (301) 796-6600 or orahqorsmanagement@fda.hhs.gov.

Questions or issues concerning technical/scientific interpretation of documents provided at the time of entry, policy, sample collection recommendations, or any other additional questions, should be addressed to CFSAN/Division of Enforcement at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov.***

Product Description:

Stevia leaves and foods containing stevia leaves, UNLESS explicitly labeled as a dietary supplement or for use as a dietary ingredient of a dietary supplement;

Charge:

***"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409." [Adulteration, Section 402(a)(2)(C)(i)]***

OASIS Charge Code: UNSAFE ADD

PROBLEM: Unsafe food additive

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)

COLOMBIA

LABORATORIOS VIDASTEVIA LTDA

Date Published : 09/18/2009

CALLE 25 No 26 06
, BOGOTA,
CO-DC COLOMBIA

45 T - - 99 All Other Products, Non-Nutritive Sweeteners

Date Published: 09/18/2009

Notes: PRODUCT: Vida Stevia, Stevia Sweet * Although this product is labeled as a
dietary supplement, references to its sweetness for use as a sugar substitute in
baking/cooking implies use as a conventional food.